Biowaiver salt vs. cocrystal [Dissolution / BCS / IVIVC]
Hi nobody
CPMP/EWP/QWP/1401/98 Rev. 1/ Corr ** states: Biowaiver is not applicable when the test product contains a different ester, ether, isomer, mixture of isomers, complex or derivative of an active substance from that of the reference product, since these differences may lead to different bioavailabilities not deducible by means of experiments used in the BCS-based biowaiver concept.
❝ Talking about EU? And BCS-based biowaivers?
❝ The EU Guideline is crystal clear, for different salts: Both have to be BCS-class I.
CPMP/EWP/QWP/1401/98 Rev. 1/ Corr ** states: Biowaiver is not applicable when the test product contains a different ester, ether, isomer, mixture of isomers, complex or derivative of an active substance from that of the reference product, since these differences may lead to different bioavailabilities not deducible by means of experiments used in the BCS-based biowaiver concept.
❝ I think often people go the "known" way, BE-study, end of game. Instead of investing time (!) and money for a task with unknown outcome.
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Biowaiver salt vs. cocrystal Dr_Dan 2017-05-24 18:56 [Dissolution / BCS / IVIVC]
- Biowaiver salt vs. cocrystal nobody 2017-05-24 20:21
- Biowaiver salt vs. cocrystalDr_Dan 2017-05-29 09:16
- Biowaiver salt vs. cocrystal nobody 2017-05-29 10:15
- Biowaiver salt vs. cocrystalDr_Dan 2017-05-29 09:16
- Biowaiver salt vs. cocrystal nobody 2017-05-24 20:21